RECLINMED s.r.o. Information

RECLINMED s.r.o., a consultancy company based in Prague, Czech Republic, provides broad range of services to pharmaceutical companies. We offer services in regulatory affairs, CMC and manufacturing, quality assurance and pharmacovigilance. Our specialization is biological/biotechnological products, vaccines and ATMP. 1. Medical writing Dossier preparation (writting modules 2, 4 & 5 for original, generics, WEU, hybrid, THMP applications) Periodic Safety Update Report, PSUR Summary of Product Characteristics, SmPC Patient Information Leaflet, PIL Direct Healthcare Professional Communication, DHPC 2. CMC & Manufacturing Preparation of CTD Modules 2&3 (registration, variations, renewals) Regulatory compliance - Gap analysis & remediation Expert reports – ERA, PDE reports Contract QP Import documentation and licensing GLP/GMP audit 3. Regulatory affairs Registration strategy Preparation applications and submissions (DCP, MRP and NP) Communication with the national competent authorities Life-cycle management (variations, renewals, line extensions, annual reporting) eCTD/NeeS publishing 4. Pharmacovigilance services Establishing and managing the system An overview of the safety profile of medicines 24 h/7 day service of QPPV Case reporting 5. Quality Assurance Performing internal/external audits Introduction and maintenance of quality systems - preparation of SOPs, working guidelines etc. for RA, pharmacovigilance, manufacture or distribution departments Assistance during the inspection processes, development of CAPA, dealing with critical findings 6. Medical devices CE certification and notification of MD ISO 13485 consultation Preparation of complete technical file Documents preparation (vigilance system, SOPs) Clinical evaluation 7. Advertising & Promotion / Labelling SPC/PIL/Labelling – preparation and translation Readibility testing Educational materials/aRMM